FDA product code QIK: Organ Care System (Ocs) Heart System
QIK is the FDA product code for organ care system (ocs) heart system. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QIK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.
Classification
| Field | Value |
|---|---|
| Device name | Organ Care System (Ocs) Heart System |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for QIK devices
openFDA lists no recalls for product code QIK.
Frequently asked questions
What is FDA product code QIK?
QIK is the FDA product code for organ care system (ocs) heart system. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QIK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QIK
- Run a recall and safety report across every QIK manufacturer
- Watch product code QIK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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